Calcium

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Archive: May not be cited for licence application purposes.

Date: November 14, 2007

Proper name(s): Calcium(Sweetman 2007; O'Neil et al. 2001)

Common name(s): Calcium(Sweetman 2007; O'Neil et al. 2001)

Source material(s):

• Bone meal*
  (HC 2007)
• Calcium acetate
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium ascorbate
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium bisglycinate
  (Albion 2000)
• Calcium carbonate
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium chloride
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium chloride dihydrate
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium chloride hexahydrate
  (Sweetman 2007; O'Neil et al. 2001)
• Calcium citrate
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium citrate malate
  (Patrick 1999)
• Calcium citrate tetrahydrate
  (Sweetman 2007; O'Neil et al. 2001)
• Calcium fumarate
  (HC 2007)
• Calcium glubionate
  (Sweetman 2007)
• Calcium glubionate monohydrate
  (Sweetman 2007)
• Calcium gluceptate
  (Sweetman 2007)
• Calcium gluconate
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium gluconate monohydrate
  (Sweetman 2007; IOM 2003)
• Calcium glutarate
  (HC 2007)
• Calcium glycerophosphate
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium hydrolyzed animal protein (HAP) chelate
  (Albion 1996; Albion 1993)
• Calcium hydrolyzed vegetable protein (HVP) chelate
  (Albion 1996; Albion 1993)
• Calcium hydroxide
  (IOM 2003)
• Calcium lactate
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium lactate gluconate
  (Sweetman 2007)
• Calcium lactate pentahydrate
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium lactate trihydrate
  (Sweetman 2007; IOM 2003)
• Calcium lactobionate dihydrate
  (Sweetman 2007; IOM 2003)
• Calcium levulinate
  (Sweetman 2007; O'Neil et al. 2001)
• Calcium levulinate dihydrate
  (Sweetman 2007; O'Neil et al. 2001)
• Calcium malate
  (HC 2007)
• Calcium oxide
  (IOM 2003)
• Calcium phosphate dibasic
  (Sweetman 2007; IOM 2003)
• Calcium phosphate monobasic
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium phosphate tribasic
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium pidolate
  (Sweetman 2007)
• Calcium pyrophosphate
  (IOM 2003)
• Calcium silicate
  (Sweetman 2007; IOM 2003; O'Neil et al. 2001)
• Calcium sodium lactate
  (Sweetman 2007)
• Calcium succinate
  (O'Neil et al. 2001)
• Calcium sulfate
  (IOM 2003)
• Calcium sulfate dihydrate
  (IOM 2003)
• Coral
  (HC 2007)
• Dolomite
  (Sweetman 2007; O'Neil et al. 2001)
• Oyster shell
  (HC 2007)

* When bone meal is used as a source material for calcium, it must be sourced from a non-human animal that is not susceptible to Transmissible Spongiform Encephalopathy (TSE) diseases, including Bovine Spongiform Encephalopathy (BSE) (HC 2006).

Route(s) of administration: Oral

Dosage form(s): Those pharmaceutical dosage forms suited to oral administration, including but not limited to chewable tablets, caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons, or tablespoons are acceptable. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s): Statement(s) to the effect of:

General: A factor in the maintenance of good health (IOM 2006; IOM 1997).

Specific:

• Helps in the development and maintenance of bones and teeth (Optional: "especially in childhood, adolescence and young adulthood") (IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 1997).
  
  If the following statement is used, it must be verbatim:
• "Calcium intake, when combined with sufficient vitamin D, a healthy diet, and regular exercise, may reduce the risk of developing osteoporosis" (Shils et al. 2006; Groff and Gropper 2000; NIH 2000).

Dose-specific: For products providing daily doses of calcium at or above the Adequate Intake (AI) (adjusted for the life stage groups), the following use or purpose is acceptable:
Helps to prevent calcium deficiency (IOM 2006; Shils et al. 2006; Groff and Gropper 2000; IOM 1997).

See Appendix 1 for definitions and Table 2 in Appendix 2 for AI values.

Dose(s):

Table 1: Dose information for calcium presented as dose per day

Life stage group		Calcium (mg/day)
		Minimum1	Maximum2
Children	1-3 y	65	1,500
	4-8 y	65	1,500
Adolescents	9-13 y	65	1,500
	14-18 y	65	1,500
Adults3	≥ 19 y	65	1,500

¹ Based on approximately 5% of the highest AI (IOM 2006). See Appendix 1 for definitions and Table 2 in Appendix 2 for AI values.
² Maximum dose based on the Tolerable Upper Intake Level (UL) less average dietary intake (adapted from IOM 2006).
³ Includes pregnant and breastfeeding women.

Directions for use: Statement(s) to the effect of:
Take a few hours before or after taking other medications (Sweetman 2007; ASHP 2005).

Duration of use: No statement required.

Risk information: Statement(s) to the effect of:

Caution(s) and warning(s): When calcium HAP or HVP chelate is used as a source material:
For an adult subpopulation only.

Contraindication(s): No statement required.

Known adverse reaction(s): No statement required.

Non-medicinal ingredients: Must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.

Specifications: Must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.

References:

Albion 2000: Implications of the "other half" of a mineral compound. Albion Research Notes 2000;9(3) [Accessed 2007-05-18]. Available from:
http://www.albion-an.com/human/Newsletter/2000October.pdf

Albion 1996: Effective calcium supplementation: not as easy as advertised!!! Albion Research Notes 1996;5(3) [Accessed 2007-03-21]. Available from:
http://www.albion-an.com/human/Newsletter/1996june.pdf

Albion 1993: Calcium absorption conflict. Albion Research Notes 1993;2(2) [Accessed 2007-03-21]. Available from: http://www.albion-an.com/human/Newsletter/1993Mar.pdf

ASHP 2005: American Society of Health-System Pharmacists. American Hospital Formulary Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins; 2005.

Groff J, Gropper S. Advanced Nutrition and Human Metabolism, 3^rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.

HC 2007: Health Canada. Drug Product Database. 2007. [Accessed 2007-05-18]. Available from: http://search.hc-sc.gc.ca/cgi-bin/query?mss=dpd/english/active/simple

HC 2006: Health Canada. Evidence for Safety and Efficacy of Finished Natural Health Products. Ottawa (ON): Natural Health Products Directorate, Health Canada; 2006. [Accessed 2007-06-07]. Available from:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/efe-paie-eng.php

IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Institute of Medicine Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press; 2006.

IOM 2003: Institute of Medicine. Committee on Food Chemicals Codex, Food and Nutrition Board, Institute of Medicine. Food Chemicals Codex, 5^th edition. Washington (DC): National Academies Press; 2003.

IOM 1997: Institute of Medicine. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D, and Fluoride. Washington (DC): National Academy Press; 1997.

NIH 2000: National Institute of Health. Osteoporosis Prevention, Diagnosis, and Therapy. NIH Consensus Statement Online 2000;17(1):1-36. Bethesda (MD): National Institute of Health; March 27-29, 2000. [Accessed 2007-03-21]. Available from:
http://www.consensus.nih.gov/2000/2000Osteoporosis111html.htm

O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 13^th edition. Whitehouse Station (NJ): Merck & Co., Inc; 2001.

Patrick L. Comparative absorption of calcium sources and calcium citrate malate for the prevention of osteoporosis. Alternative Medicine Review 1999;4(2):74-85.

Shils ME, Olson JA, Shike M, Ross AC, editors. Modern Nutrition in Health and Disease, 10^th edition. Philadelphia (PA): Lippincott Williams and Wilkins; 2006.

Sweetman SC, editor. Martindale: The Complete Drug Reference, 35^th edition. London (UK): Pharmaceutical Press; 2007.

Appendix 1: Definitions

Adequate Intake (AI): The recommended average daily intake level based on observed or experimentally determined approximations or estimates of nutrient intake by a group (or groups) of apparently healthy people that are assumed to be adequate. An AI is used when an RDA cannot be determined (IOM 2006).

Recommended Dietary Allowances (RDA): The average daily dietary nutrient intake level sufficient to meet the nutrient requirements of nearly all (97-98%) healthy individuals in a particular life stage and gender group (IOM 2006).

Tolerable Upper Intake Level (UL): The highest average daily nutrient intake level that is likely to pose no risk of adverse health effects to almost all individuals in the general population. As intake increases above the UL, the potential risk of adverse effects may increase (IOM 2006).

Appendix 2: AI Values

The AI values for calcium are provided below. For the purpose of this monograph, these values are intended to:

• provide targets for setting appropriate supplement dosage levels;
• provide the minimum dose for the use of the dose specific use or purpose: "Helps to prevent calcium deficiency";
• facilitate the optional labelling of % AI values.

Table 2: Adequate Intake values for calcium based on life stage group (IOM 2006)

Life stage group		Calcium (mg/day)
Children	1-3 y	500
	4-8 y	800
Adolescents	9-18 y	1,300
Adults	19-50 y	1,000
	≥ 51 y	1,200
Pregnancy	14-18 y	1,300
	19-50 y	1,000
Breastfeeding	14-18 y	1,300
	19-50 y	1,000